Recruiting

Technology-Enhanced Protocol & Standard Examination

Sponsor:

University of Michigan

Code:

NCT06934577

Conditions

Eye Diseases

Visual Impairment

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard optometric examination

Technology enhanced eye disease detection protocol

Study Details

Brief summary:

To compare eye disease detection rates at a Federally Qualified Health Center between a technology-enhanced protocol and standard optometric clinical examination for three of the leading causes of blindness: glaucoma, diabetic retinopathy, and visually significant cataract.

Conditions

Eye Diseases

Visual Impairment

Glaucoma

Study ID

NCT06934577

Start date

Dec 4, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Speak English, Spanish, Arabic, Chinese, French, Hindi, Finnish, Albanian, Russian or Tagalog

Exclusion Criteria:

  • significant eye pain
  • sudden decrease in vision within one week
  • binocular diplopia
  • cognitive impairment
  • pregnancy
  • previously declined participation

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Control, standard optometric examination

Participants will receive usual care with an optometrist with a biomicroscopic exam at the Federally Qualified Health Center to identify eye disease.

experimental: Intervention, technology enhanced eye disease detection protocol

Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (if no disease is detected) or an in-depth appointment with the optometrist (if there is disease detected).

Interventions

Standard optometric examination

Participants will see the optometrist at the Federally Qualified Health Center. The guidelines define usual care as: an in-person comprehensive eye examination with assessment of patient history, visual acuity, pupil examination, ocular motility and alignment, intraocular pressure, and biomicroscopy with additional tests, as appropriate. A glasses prescription will be given to the participant if needed. Participants will complete surveys at baseline before their eye exam and 6 weeks after the eye exam.

Technology enhanced eye disease detection protocol

Participants will receive a technology enhanced eye disease detection protocol from ophthalmic technicians that includes measurements of visual function such as visual acuity, refraction, intraocular pressure, pachymetry, external eye and fundus photography, and optical coherence tomography of the macula and retinal nerve fiber layer. The optometrist at the Federally. Qualified Health Center will then use a protocol to grade the testing and identify eye disease. The results of the grading will inform whether the person receives a brief appointment with the optometrist (no disease detected) or an in-depth appointment with the optometrist (disease detected). During the first visit, participants receive care navigation support to purchase low-cost glasses from an on-line retailer. When participants return for the optometrist exam, glasses will be fit. Participants will receive care navigation support to attend any recommended specialty follow-up appointments.

Primary outcome measure

  • Rate of vision threatening eye disease (glaucoma/suspected glaucoma, visually significant cataract, diabetic retinopathy) [ Time Frame: Visit 1(day 1) ]
  • Rate of glaucoma/suspected glaucoma [ Time Frame: Visit 1 (Day 1) ]
  • Rate of visually significant cataract [ Time Frame: Visit 1(day 1) ]
  • Rate of diabetic retinopathy [ Time Frame: Visit 1(day 1) ]

Central Contacts and Locations

Central contacts

Locations

Hamilton Optometry Clinic

Recruiting

Flint, Michigan, United States, 48505.

Contacts

Principal Investigator:

Paula Anne Newman-Casey, MD

More Information

Sponsor

University of Michigan

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Eye disease screening
  • Glaucoma detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-15.